This invention is directed to a therapeutic device for the use in treating people who have undergone surgical removal of a limb by applying the device to the amputee""s residual limb. In particular, the invention is directed to a therapeutic device intended for use in the immediate post-operative phase, i.e., immediately after surgical amputation of a limb. More specifically, the invention is directed to a therapeutic prosthesis intended to reduce edema and pain and to promote healing and proper residual limb formation after surgery, while providing support for partial weight-bearing and prosthetic gait training by the amputee and being adjustable to fit a wide range of sizes of residual limbs.
Early fitting of a prosthesis is critical to an amputee""s successful rehabilitation. It is very important for the amputee to resume physical activity as soon as possible, after amputation both for physical as well as psychological reasons and because the application of compression to the residual limb is beneficial to the healing process. The early use of a prosthesis helps the amputee quickly re-establish a bilateral body image and accept the use of a prosthetic device. The use of a prosthetic device soon after amputation surgery prevents muscle contractures and loss of muscle strength in the amputee, protects the residual limb from trauma, and helps the amputee develop a tolerance to weight bearing and to learn to balance on a prosthesis. Overall, early use of a post-operative prosthesis reduces complications and the length of the hospital stay for the amputee, and speeds up the training and adjustment period for the new prosthetic device user.
While the residual limb heals after surgery, the amputee cannot be immediately fitted with a rigid socket permanent prosthesis because of wound healing issues, swelling and the need for dressing. Following surgery, the residual limb undergoes dramatic changes in size and shape. To accommodate these changes, various preparatory or interim prostheses are employed as a temporary measure prior to a permanent fitting. A new amputee typically goes through several stages of prosthetic devices while the residual limb is healing and maturing to a stable shape and size. The amputee is eventually provided with a permanent prosthesis, usually a custom-molded socket attached to a metal pylon with a foot. A permanent prosthesis is used on a continuing basis until the device wears out or the amputee experiences changes to the residual limb.
In the immediate post-surgical stage, i.e., during the first several weeks after surgery, amputees may be provided with a rigid dressing, such as a plaster of Paris socket or an initial post-operative prosthesis (xe2x80x9cIPOP.xe2x80x9d), to protect and mold the residual limb. These dressings, however, have limited usefulness because they are non-removable and non-adjustable.
As a more common alternative, to enhance shrinkage and permit access to the surgical wound, elastic bandages and wraps are sometimes used. However, use of such bandaging may lead to skin breakdown and distal edema, and does not protect against developing a contracture or wound trauma. To avoid these complications, a removable rigid dressing can be used. Such prior art removable rigid dressings (xe2x80x9cRRDxe2x80x9d) are described more fully in an article entitled xe2x80x9cRemovable Rigid Dressing for Below-knee Amputees,xe2x80x9dby Yeongchi Wu and Harold Krick, appearing in Clinical Prosthetics and Orthotics, Vol. 11, No. 1, pp. 33-44 (1987).
The authors of that prior art article state that their removable rigid system reduces pain, prevents residual limb trauma, promotes soft tissue immobilization to facilitate wound healing, fosters rapid maturation of the residual limb, leads to more rapid shrinkage, and provides effective edema control. They further clam that with a removable rigid post-operative dressing, there is less change in residual limb volume once the amputee is ready for a preparatory or interim prosthesis, thus, there is less need for costly socket changes.
While such rigid dressings of the prior art have been beneficial, they also have certain disadvantages. In particular, these systems are not easily adjustable in response to changes in the size and shape of the residual limb. Also, the device must be removed from the residual limb to make adjustments to these prior art systems. To adjust the fit or prior art systems, socks may be added or removed, but only slight adjustments are possible with this technique. Moreover, prior art RRD systems do not act as prostheses, so immediate psychological benefits to the amputee are not achieved. Since the RRD device can only be donned from the open end it does not effectively provide compression over the entire residual limb if the limb has the common bulbous shape of most new amputations.
It is an object of the present invention to provide a new system for post-operative treatment of a residual limb of an amputee. More specifically, it is an object of the present invention to provide a therapeutic prosthetic device for immediate post-surgical use that reduces edema and pain, protects the residual limb of an amputee from trauma, is easily fitted about the residual limb, allows for easy access to the residual limb so that medical personnel will be able to easily check the wound, and promotes healing and proper residual limb formation after surgery.
It is a further object of the present invention to provide a therapeutic device for the residual limb of an amputee that uses an external adjustable shell and internal adjustable bladders to fine tune adjustments in pressure to the residual limb without removing the shell or undoing the system. Such a system would easily accommodate changes in the size and shape of the residual limb and also allow for the use of bulky dressings. Such a system could also be used with an attachable pylon and foot to promote symmetrical body image and the psychological well-being of the amputee, and will also permit early partial weight bearing.
It is a still further object of the present invention to provide a method for treating a residual limb of an amputee in the post-operative stage to reduce edema and pain, and to promote proper healing and formation of the residual limb. Other objects, advantages, and novel features of the instant invention will be readily apparent to those of skill in the art from the following drawings and detailed description.
The present invention is directed to a therapeutic device for post-operative treatment of a residual limb of an amputee. The therapeutic device comprises a shell into which the associated residual limb is placed. The shell has a first shell portion and a second shell portion consisting of two overlapping parts. The second shell portion is movable between a position wherein the shell is closed and the residual limb is enveloped therein and a position wherein the shell is open and the residual limb is thereby exposed. A fastening means may be provided for securing the second shell portion to the first shell portion. This fastening means may secure the second shell portion in its first position wherein the shell is closed.
The second shell portion may include a first movable section and a second movable section. Each of these sections may be attached along a respective longitudinal edge thereof to the first shell portion, and they may be pivotable about their respective longitudinal edges. In another embodiment of the invention, the first shell portion includes a receiving means and the second shell portion includes an extension means. In this embodiment, the extension means of the second shell portion is received in the receiving means of the first shell portion when the second shell portion is moved to a position wherein the shell is closed and the residual limb of the amputee is enveloped therein.
The shell may further include a third shell portion adapted to receive the distal end of the residual limb. This third shell portion may be disposed adjacent to the first and second shell portions. A fourth piece may be inserted posteriorly of the shell running up the back of the thigh to prevent knee flexion.
A plurality of inflatable bladders are disposed within the shell. These inflatable bladders may be secured to and extend along the inner surfaces of the first and second shell portions. If the second shell portion includes first and second movable sections, the inflatable bladders may be secured to and extend along the inner surfaces of these movable sections and along the inner surface of the first shell portion. If the shell is provided with a third shell portion, one or more inflatable bladders may likewise be secured to and extend along the inner surface thereof.
Adjacent surfaces of at least two of the inflatable bladders may overlap, and a pump means may be provided for inflating and deflating the bladders. In this regard, a separate fluid pump supply may be provided for independently inflating and deflating each of the inflatable bladders. The combination of the rigid but adjustable shell and inflatable bladders awards the requirement of certain molding of the device as will be noted, facilitating healing.
The present invention is also directed to a method of treating a residual limb of an amputee in the post-operative stage to reduce edema and pain, and to promote proper healing an formation of the residual limb. In the method of the present invention, a therapeutic device having a shell and a plurality of inflatable bladders disposed along the inner surface thereof is provided. The shell of the therapeutic device is opened and the residual limb is placed therein. The shell is closed about the residual limb and therapeutic pneumatic pressure is applied to the residual limb through the plurality of inflatable bladders in cooperation with the shell. This therapeutic pneumatic pressure may be applied by inflating at least one of the plurality of inflatable bladders, and the pressure may be varied and measured in response to the change in shape of the residual limb during the healing process. The therapeutic pneumatic pressure can be adjusted by inflating or deflating at least one of the plurality of inflatable bladders.
After therapeutic pneumatic pressure has been applied to the residual limb, the shell may be opened and the residual limb examined. The shell may then be closed about the residual limb and therapeutic pneumatic pressure re-applied to the residual limb through the plurality of inflatable bladders in cooperation with the shell. Again, the therapeutic pressure may be applied by inflating at least one of the plurality of inflatable bladders.